Blog Tag: Apple
AliveCor, Inc., a company focused on cardiac data and remote medicine, successfully convinced an International Trade Commission (ITC) judge that Apple, Inc. infringed multiple AliveCor patents related to electrocardiogram (ECG) technology. AliveCor asserted that the Apple Watch (Series 6 and 7) infringes multiple AliveCor ECG patents and seeks to ban the watches from importation into the U.S.
In a June 27, 2022 Notice of Initial Determination, an ITC Administrative Law Judge (“ALJ”) agreed with AliveCor, determining Apple had violated Section 337 of the Tariff Act of 1930 (19 U.S.C. § 1337), related to “Unfair practices in import trade.” The ALJ found the ECG functionality of the Apple Watch Series 6 and Series 7 (pictured below) infringed multiple, valid claims of two AliveCor patents: U.S. Patent Nos. 10,638,941 (titled “Discordance Monitoring”) and 10,595,731 (titled “Methods and Systems for Arrhythmia Tracking and Scoring”).
AliveCor is the complainant in ITC Investigation No. 337-TA-1266 (the “1266 Investigation”), captioned Certain Wearable Electronic Devices with ECG Functionality and Components Thereof. A public version of the ALJ’s complete Initial Determination should be released soon. By October 26, 2022, the full ITC is expected to issue a final decision in the 1266 Investigation. If the Commission affirms the ALJ’s findings, the Apple Watch Series 6 and Series 7 could be banned from importation into the United States.
According to an Apple press release, iPhone users will now be able to store and view their medical records on their phones as part of a new feature found in iOS 11.3. Although many patients are already familiar with clinic-specific patient portals, Apple’s new Health Records feature is said to allow patients to download their medical records from a variety of hospitals and clinics, and consolidate those records on their iPhone.
According to Apple, the Health Records feature can be found in Apple’s Health app on updated devices. The Health Records feature allows participating hospitals and clinics to transfer medical information to a users device. The patient’s medical record data will be stored along with their own patient-generated data in the consolidated Health app. Users will be able to view recorded allergies, clinical vitals, conditions, immunizations, lab results, medications, procedures, and similar information. Users will also be notified whenever their data is updated, such as when lab results are received.
Apple notes that in the past, patients’ medical records were held in multiple locations, requiring patients to log into each care provider’s website and piece together the information manually.
The press release notes that data within the Health Records feature will be encrypted and protected with the user’s iPhone passcode. Moreover, no health record data passes through Apple’s network. Instead, Apple relies on Fast Healthcare Interchangeability Resources (FHIR) and related application programming interfaces (APIs) to transmit the data from a hospital or clinic’s electronic health record (EHR) system directly to a user’s device over an encrypted connection.
As a result, Apple maintains that it does not create, transmit, or receive any protected health information for or on behalf of a covered entity or business associate. Nevertheless, if a user chooses to sync their health data with iCloud, the data will be encrypted in transit and for storage on Apple’s servers.
With the push to provide patients with their digital health information comes a push for FHIR, solidifying the technology’s viability as a solution to the federal mandate that providers allow patients to access electronic versions of their health records
Apple notes that at this time, around 40 hospitals and clinics are participating, including Johns Hopkins, Cedars-Sinai, Penn Medicine, UC San Diego Health, and Geisinger Health System.
According to the annual Top 100 Verdicts report by ALM’s VerdictSearch, five jury verdicts for Intellectual Property cases cracked the top 10 with a sixth breaking into the top 25 verdicts of 2016. While the amounts do not account for judicial reductions, offsets or appeals, the report indicates that the more than $4.67 billion in total jury awards from the top 6 IP verdicts alone show that intellectual property cases dominated the Top 100 in terms of total dollars awarded.
The publication ranked Idenix‘s $2.54 billion royalty share of Gilead Sciences‘ profits from two blockbuster hepatitis C drugs as the #1 IP verdict and #3 overall on its list of “Top 100 Verdicts of 2016.” According to the report, Idenix successfully asserted that Gilead willfully infringed Idenix’s patents relating to an antiviral compound used in the treatment of hepatitis C, resulting what commentators have stated is the largest patent infringement verdict in U.S. history.
The second highest IP verdict in VerdictSearch’s 2016 list, $940 million (including $700 million in punitive damages), went to medical software company Epic Systems in what commentators have said is one of the largest trade-secrets verdicts on record. According to the report, Epic successfully asserted that Tata misappropriated information related to Epic’s health care software.
The #3 and #4 IP verdicts of 2016 according to VerdictSearch, $625 million and $302 million, respectively, went to technology patent-holder VirnetX for infringement of four of VirnetX’s internet security patents infringement by several Apple products, including iPhones and iPads.
Merck won the 5th largest IP verdict of the year according to VerdictSearch, a $200 million award against Gilead. The report noted that Gilead Sciences v. Merck & Co. involved infringement of different patents relating to the same drug compound as the Idenix case. The case was filed by Gilead as a declaratory judgment action, but Merck & Co. won on its counterclaim.
CardiAQ‘s $70 million win in CardiAQ Valve Technologies, Inc. v. Neovasc Inc. was listed in VerdictSearch as the #6 IP verdict and tied for #21 overall. As noted in a previous post here, according to the report, the jury found that Neovasc breached the non-disclosure agreement between the parties, misappropriated CardiAQ’s trade secrets, and breached its duty of honest performance to CardiAQ.
According to the report, the 11 IP verdicts in the top 100 totaled approximately $4.8 billion, more than a threefold increase from 2015, when the total was $1.43 billion.
Apple announced CareKit on Monday, a new, open-source software framework designed to help app developers in the medical care space enable people to actively manage their own medical conditions. The press release states that:
“[A]pps using CareKit make it easier for individuals to keep track of care plans and monitor symptoms and medication; providing insights that help people better understand their own health. With the ability to share information with doctors, nurses or family members, CareKit apps help people take a more active role in their health.”
According to the press release, CareKit is not an app itself but rather a software developer kit, or SDK, that can be used by the developer community to create apps. As such, general users of Apple’s products won’t directly use CareKit, but in the near future those with specific health needs may find themselves using third-party software designed using Apple’s new platform. Apple’s press release indicates that apps already being built using this SDK. These include apps for Parkinson’s disease patients, post-surgery progress, managing chronic health conditions, home health monitoring, diabetes management, mental health and maternal health.
According to the press release, CareKit will be released as an open source framework allowing the developer community to build on the first four modules designed by Apple. Apple’s existing modules include: (1) Care Card for helping people track individual care plans and action items; (2) Symptom and Measurement Tracker for recording patient symptoms; (3) Insight Dashboard for mapping symptoms in the Symptom and Measurement Tracker against the action items in the Care Card to show how treatments are working; and (4) Connect for sharing of information and communication with care providers.
Apple recently released ResearchKit, an open-source software platform that allows scientists to gather medical data using an individual’s own iPhone. According to The Asian Age, the new platform allows iPhone users to easily and voluntarily join medical research studies while deciding how their data is shared with researchers.
ResearchKit enables researchers to learn about a patient’s gait, motor impairment, fitness, speech, and memory by accessing the iPhone’s built-in sensors (e.g., accelerometer, microphone, gyroscope and GPS sensors). The new software builds on Apple’s HealthKit software, which was announced last year. HealthKit allows applications that provide health and fitness services to share their data with HealthKit and with each other. With the release of ResearchKit, users will be able to send data gathered through the HealthKit application, such as information on blood pressure, weight, blood glucose levels, and exercise habits, to medical researchers partnering with Apple.
Jeff Williams, Apple’s Senior Vice President of Operations, said:
With hundreds of millions of iPhones in use around the world, we saw an opportunity for Apple to have an even greater impact by empowering people to participate in and contribute to medical research.
Several research institutions, such as Stanford University School of Medicine and Weill Cornell Medical College, have already partnered with Apple to create software applications for ResearchKit for use in clinical studies on asthma, heart disease, diabetes, and Parkinson’s disease.